A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01226719
Protocol IDs
SCRI GI 134 (primary)
Study Sponsor
Sarah Cannon Research Institute

Summary

In this Phase II study the investigators plan to determine the overall response rate (ORR)of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

Objectives

Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer. For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection. Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI. Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS. In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.

Treatment Sites in Georgia


Longstreet Cancer Center - Gainesville
725 Jesse Jewel Parkway
3rd Floor
Gainesville, GA 30501
www.longstreetclinic.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Timothy M. Carey MD
Anup K. Lahiry MD
Richard J. LoCicero MD
Charles H. Nash, III MD, FACP

Northeast Georgia Diagnostic Clinic - Gainesville
1240 Jesse Jewell Parkway
Suite 500
Gainesville, GA 30501
www.ngdc.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Padma C. Nadella MD
Saloni H. Tanna MD
Christina A. Saurel MD

Surgical Oncology of Northeast Georgia
690 Medical Park Lane
Gainesville, GA 30501
www.drkendixon.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

P. Kendal Dixon MD

Toccoa Cancer Center
1640 Falls Road
Toccoa, GA 30577
www.nghs.com

Study Coordinator:
Patti Rotunda
(770) 219-8826

Doctors:

Geoffrey J. Weidner MD